Sanofi Group Clinical Research Director – Neurology Development in Cambridge, Massachusetts
The Clinical Research Director is responsible for leading successful clinical trials for novel therapeutics for Neurological Diseases. This key role requires solid knowledge in clinical trial design and conduct, as well as organizational, analytical and operational skills. The CRD will work closely with cross-functional colleagues to optimize clinical strategy and operationalize and conduct successful clinical trials.
The Neurology Development unit is a project-based organization. CRDs typically report within projects lead by Global Project Heads. Colleagues within Neurology Development include physicians and scientists with deep clinical, scientific and development experience in neuroscience. We are looking for individuals with curiosity, scientific mindset and appreciation of teamwork with a diverse group of internal and external experts.
The CRD provides scientific and technical expertise:
Has and maintains deep scientific and clinical expertise in the field of Neurology.
Understands and keeps updated with the pre-clinical, clinical pharmacology and other data relevant to the molecule of interest.
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products.
Achieves visibility within the Neurology Development Therapeutic Area and maintains credibility with internal and external stakeholders.
Designs global clinical studies in close cooperation with other members of the team, particularly Statistics, Regulatory Affairs and Health Economics.
Contributes to the life cycle management strategy for the project whenever appropriate.
Implementing strategies to identify, monitor and resolve clinical program/trial issues.
Key clinical contributor for the protocol synopsis and the detailed Protocol for their projects.
Serving as the Study Director and Medical Monitor for a study or clinical program as well as reviewing and monitoring study data.
The CRD will provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
Prepares the clinical part of regulatory documents such as meeting requests and briefing packages for meetings with Regulatory agencies.
Works with the study team to prepares answers to questions from Regulatory Agencies and Institutional Review Boards.
Implements strategies to identify, monitor and resolve clinical program/trial issues.
Collaborates with functions to ensure uniform, aligned operational approach (eg harmonizing study documents, protocols, etc.),as relevant.
Prepares, with the support of the medical writing department, the clinical parts of clinical study reports and other clinical summaries. Reviews other study related documents (clinical pharmacology, summary of clinical safety) whenever appropriate.
Contribute to publications and communication of study results.
Understanding of pharmaceutical product development and life-cycle management gained through 3-5 years of clinical development and medical experience.
Good scientific and medical expertise in the field of Neurology.
Good expertise in clinical development and methodology of clinical studies.
Good communication skills (verbal and written) for interactions across functional areas and for interactions with regulatory agencies.
Ability to work within a matrix model.
Minimum Level of any Required Qualifications:
Medical Doctor (MD) preferred, but not required. PhD or similar level of training is acceptable.
Clinical specialty or other relevant experience in the field of Neurology.
Fluency in written and spoken English.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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